CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiRx, Inc.
About this trial
CVM-1118 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human has been evaluated from the phase 1 study. The objective of the phase 2 study is to further investigate the efficacy of CVM-1118 with nivolumab for subjects with unresectable advanced hepatoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18+ (20+ for subjects in Taiwan)
Diagnosis of hepatocellular carcinoma
Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion)
Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab).
Disqualifiers
HCC with portal vein invasion at the main portal branch (Vp4)
Known history of esophageal varices or gastrointestinal bleeding within the past 3 months
Prior immunotherapy for hepatoma
≤ 7 days from prior limited field palliative irradiation therapy and C1D1
Trial design
Design model
Single group
Treatments tested in this trial
Nivolumab Injection [Opdivo]
DrugNivolumab will be administered at 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting with Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability.
CVM-1118
DrugCVM-1118 will be administered 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects.
Treatment groups
95 Participants
are divided into 1 treatment groupGroup A: Nivolumab + CVM-1118Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)_mRECIST
Assessment by modified RECIST criteria
Time frame
24 weeks after the last subject starts CVM-1118Secondary outcomes
1
Objective Response Rate (ORR)_RECIST v1.1
Assessment by RECIST v1.1 criteria
Time frame
24 weeks after the last subject starts CVM-11182
Duration of response (DoR)
Duration of response (DoR) is defined as time from the first documentation of response to the time of progression
Time frame
24 weeks after the last subject starts CVM-1118 up to 1 year after the last-dose3
Progression free survival (PFS)
Progression free survival (PFS) is defined as time from the first dose of study drug to the time of progression or death
Time frame
24 weeks after the last subject starts CVM-1118 up to 1 year after the last-dose4
Overall survival (OS)
Overall survival (OS) is defined as time from first dose of study drug to death
Time frame
24 weeks after the last subject starts CVM-1118 and up to 1 year after the last-doseSponsors and contacts
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Source ClinicalTrials.gov